ENSAL ENTERIC MIXTURE
Page 1 of 7
ISSUED:
29 August 2016
SAFETY DATA SHEET
Section 1: IDENTIFICATION of CHEMICAL PRODUCT and COMPANY
Product Name:
Ensal Enteric Mixture
Product Code:
60280 (120 mL)
Recommended Use:
For the oral treatment of bacterial infections of the gastrointestinal tract in cats
and dogs.
Restrictions on Use:
For animal treatment only.
Company Identification:
Jurox Pty Limited
Address:
85 Gardiner Street,
Rutherford, NSW 2320,
Australia
Email:
[email protected]
Customer Centre:
1800 023 312
National Poisons
Information Centre:
13 1126 (Australia-wide)
Emergency Telephone
Number:
1800 023 312 (9am – 5pm, Monday to Friday)
Section 2: HAZARDS IDENTIFICATION
Hazard Classifications: This product has been assessed according to GHS and is classified as follows:
GHS Category
Specific target organ toxicity - repeated
exposure Category 2
Signal word:
Hazard code
H373
Hazard Statement
May cause damage to organs through
prolonged or repeated exposure.
WARNING
GHS Pictograms:
Health hazard
Precautionary statements:
Prevention
P260 Do not breathe vapours.
Response
P314 Get medical advice/attention if you feel unwell.
Disposal
P501 Dispose of unused product and empty container by wrapping with paper and putting in garbage.
Issued by: Jurox Pty Limited
Phone: 1800 023 312
Poisons Information Centre: 13 1126 from anywhere in Australia
ENSAL ENTERIC MIXTURE
Page 2 of 7
Section 3: COMPOSITION / INFORMATION on INGREDIENTS
INGREDIENT
CAS No.
1332-58-7
CONTENT
10 %
Phthalylsulfathiazole
85-73-4
5%
Calcium gluconate
299-28-5
2%
Potassium gluconate
299-27-4
1%
Monosodium glutamate
142-47-2
0.5 %
Hyoscine methobromide
155-41-9
0.02 %
Kaolin
Ingredients not contributing to the hazards
~ 80 %
Section 4: FIRST AID MEASURES
General Information: Never give fluids or induce vomiting if a patient is unconscious or convulsing
regardless of cause of injury. If medical advice/attention is needed, have this SDS, product container or label
at hand.
Symptoms and Effects of Exposure: None known.
Inhalation: If fumes, aerosols or combustion products are inhaled remove from contaminated area. If
respiratory symptoms occur, remove patient to fresh air. Lay patient down and keep warm and rested. If
breathing is shallow or has stopped, ensure airway is clear and apply resuscitation. If breathing is difficult,
give oxygen and seek medical assistance immediately.
Ingestion: If swallowed do NOT induce vomiting. Give water to rinse out mouth, then provide liquid slowly
and as much as casualty can comfortably drink. Never give liquid to a person showing signs of being sleepy
or with reduced awareness; i.e. becoming unconscious. If vomiting occurs, lean patient forward or place on
left side (head-down position, if possible) to maintain open airway and prevent aspiration. Observe the patient
carefully.
Skin: If skin contact occurs: Immediately remove all contaminated clothing, including footwear. Flush skin and
hair with running water (and soap if available). Seek medical attention in event of irritation.
Eye: If eye contact occurs: Immediately flush the eye continuously with running water. Ensure complete
irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally lifting
the upper and lower lids. Continue flushing for at least 20 minutes. If eye irritation persists, get medical
advice/attention.
Recommended First Aid Facilities: Ready access to running water and soap is required. Accessible
eyewash is required.
Advice to Doctor: Treat symptomatically.
Section 5: FIRE FIGHTING MEASURES
Flash Point: No data for mixture.
Hazardous Combustion Products: If involved in a fire, may emit noxious and irritant fumes.
Extinguishing Media: There is no restriction on the type of extinguisher which may be used. Use
extinguishing media suitable for surrounding area.
Protective Equipment: Protective gloves and breathing apparatus.
HAZCHEM Code: None specified.
Issued by: Jurox Pty Limited
Phone: 1800 023 312
Poisons Information Centre: 13 1126 from anywhere in Australia
ENSAL ENTERIC MIXTURE
Page 3 of 7
Section 6: ACCIDENTAL RELEASE MEASURES
Spills and Disposal: Wear gloves and appropriate protective clothing. For small spills, clean up spilled
product then wipe area and put empty container in garbage. For large spills, exclude non-essential people
from the area. Prevent spillage from entering drains or water courses and call emergency services.
Protective Clothing: For appropriate personal protective equipment see section 8.
Environmental Precautions: Prevent from entering drains, waterways or sewers. If spill does enter
waterways contact local authority.
Section 7: HANDLING AND STORAGE
Handling: Handle this product to avoid exposure, taking all recommended precautions. Avoid contact with
skin, eyes and inhalation of vapours. Use personal protective equipment as required. Do not eat, drink or
smoke while handling product.
Storage: Keep out of reach of children. Store below 25ºC (air conditioning).
Other Information: Avoid contact with incompatible substances as listed in Section 10. Always read the label
before use.
Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
This SDS describes personal protective measures relating to long term industrial and manufacturing
exposure and emergency situations, such as accidents and spills. See product label for personal
protective measures during normal use of the marketed product.
Exposure Limits: No exposure limits have been assigned for this product. Known exposure limits for ingredients are as
follows:
Source
TWA
Australia Exposure
Standards
10 mg/m
TEEL-1
3
2 mg/m
TEEL-2
3
2 mg/m
INGREDIENT
Kaolin
EMERGENCY LIMITS
INGREDIENT
Kaolin
STEL
3
Not available
TEEL-3
3
4.6 mg/m
Engineering Controls: Handle in a well ventilated area. Ensure that the work environment remains clean.
Personal Protective Equipment (PPE):
Eye protection: Protective glasses or goggles are recommended when handling bulk quantities of this
product.
Skin protection: When handling bulk product, prevent skin contact by wearing chemical protective gloves e.g.
PVC.
Respiratory protection: Not required for the normal use of this product.
Issued by: Jurox Pty Limited
Phone: 1800 023 312
Poisons Information Centre: 13 1126 from anywhere in Australia
ENSAL ENTERIC MIXTURE
Page 4 of 7
Section 9: PHYSICAL AND CHEMICAL PROPERTIES
Appearance:
Viscous off white suspension
Odour:
Not available
Odour threshold:
Not available
pH:
4.5 - 5.5
Melting Point:
Not applicable
Boiling Point:
Not available
Flash Point:
Not available
Evaporation Rate:
Not available
Flammability:
Not flammable
Upper flammability
limits:
Not available
Lower flammability
limits:
Not available
Vapour Pressure:
Not available
Vapour density:
Not available
Relative density:
Not available
Specific Gravity:
1.13 – 1.60
Solubility in Water:
Mixes with water
Partition coefficient:
Not available
Auto-ignition
temperature:
Not available
Decomposition
temperature:
Not available
Viscosity:
Not available
Section 10: STABILITY AND REACTIVITY
Reactivity: This product is unlikely to react or polymerise under normal storage conditions.
Stability: When stored appropriately this product should show no significant degradation within the expiry
period shown on the label.
Conditions to Avoid: Extreme temperatures.
Incompatible Materials: Oxidising agents.
Hazardous Decomposition Products: No data available.
Section 11: TOXICOLOGICAL INFORMATION
Acute Toxicity:
Ingestion: No data for the mixture is available. Based on available data for the ingredients, the mixture is not
considered to be acutely toxic by the oral route.
Kaolin: Oral LD50: 149,000 mg/kg (rat);
Phthalylsulfathiazole: Oral LD50: 10,000 mg/kg (mouse);
Calcium gluconate: Oral LDLo: 10,000 mg/kg (mouse);
Potassium gluconate: Oral LD50: 9,100 mg/kg (mouse).
Inhalation: No data for the mixture is available. Based on available data for the ingredients, the mixture is not
considered to be acutely toxic by the inhalation route.
Potassium gluconate: Oral LD50: > 2000 mg/kg (mouse).
Dermal: No data for the mixture is available. Based on available data for the ingredients, the mixture is not
considered to be acutely toxic by the dermal route.
Skin Corrosion / Irritation: No data for the mixture is available. Based on available data for the ingredients,
the mixture is not considered to be a skin irritant.
Serious Eye Damage / Irritation: No data for the mixture is available. Based on available data for the
ingredients, the mixture is not considered to be an eye irritant.
Issued by: Jurox Pty Limited
Phone: 1800 023 312
Poisons Information Centre: 13 1126 from anywhere in Australia
ENSAL ENTERIC MIXTURE
Page 5 of 7
Respiratory or Skin Sensitisation: No data for the mixture is available. Based on available data for the
ingredients, the mixture is not considered to be a skin sensitiser or respiratory sensitiser.
Germ Cell Mutagenicity: No data for the mixture is available. Based on available data for the ingredients, the
mixture is not considered to be mutagenic.
Carcinogenicity: No data for the mixture is available. Based on available data for the ingredients, the mixture
is not considered to be carcinogenic. Kaolin has been classified by the IARC as Group 1: CARCINOGENIC
TO HUMANS, for inhalation exposure ONLY.
Reproductive Toxicity: No data for the mixture is available. Based on available data for the ingredients, the
mixture is not considered to be a reproductive toxicant.
STOT: Single exposure: No data for the mixture is available. Based on available data for the ingredients, the
mixture is not considered to be a specific target organ toxicant after repeat exposure.
STOT: Repeat exposure: No data for the mixture is available. Based on available data for the ingredients,
the mixture is classified as Specific target organ toxicity - repeated exposure Category 2.
Aspiration hazard: No data available.
Section 12: ECOLOGICAL INFORMATION
Ecotoxicity: No data for the mixture is available. Based on available data for the ingredients, the mixture is not
considered to be ecotoxic.
Fish
Kaolin: No data;
Phthalylsulfathiazole: LC50 (96h): 258.4 mg/L;
Calcium gluconate: No data;
Potassium gluconate: LC50 (96h): > 100 mg/L, NOEC (96h): 100 mg/L.
Crustacea
Kaolin: No data;
Phthalylsulfathiazole: EC50 (48h): 19.1 mg/L, EC50 (96h): 118.5 mg/L;
Calcium gluconate: No data;
Potassium gluconate: EC50 (48h): > 1000 mg/L.
Algae and other aquatic plants
Kaolin: No data;
Phthalylsulfathiazole: EC50 (96h): 614.4 mg/L;
Calcium gluconate: No data;
Potassium gluconate: No data.
Persistence:
Water/Soil
No data
Persistence:
Air
No data
HIGH
HIGH
Calcium gluconate
No data
Potassium gluconate
No data
Ingredient
Kaolin
Phthalylsulfathiazole
Bioaccumulation
Mobility
No data
No data
LOW
(LogKOW = 2.58)
No data
No data
LOW
(KOC = 685.1)
No data
No data
No data
No data
Section 13: DISPOSAL INFORMATION
Product Disposal: Dispose of product only by using according to label or at an approved landfill.
Container Disposal: Dispose of empty container by wrapping with paper and putting in garbage.
Issued by: Jurox Pty Limited
Phone: 1800 023 312
Poisons Information Centre: 13 1126 from anywhere in Australia
ENSAL ENTERIC MIXTURE
Page 6 of 7
Section 14: TRANSPORT INFORMATION
Dangerous Goods Classification: Not considered a Dangerous Good for land, sea and air transport.
Section 15: REGULATORY INFORMATION
Poison Schedule (SUSMP): S4
APVMA No.:
36286
AICS: All of the significant ingredients in this formulation are compliant with NICNAS regulations.
Section 16: OTHER INFORMATION
This information is based on data believed by Jurox Pty Limited to be accurate at the time of writing but is subject to change without notice. It is given
in good faith, but no warranty expressed or implied is made as to its accuracy, completeness otherwise and no assumption of liability from howsoever
arising is made by Jurox Pty Limited by reason of the provision of this information. Every person dealing with the materials referred to herein does so
at his/her own risk absolutely and must make independent determinations of suitability and completeness of information from all sources to ensure
their proper use.
Legend:
AICS
CAS No.
EC50
GHS
Hazchem Code
KOC
KOW
LC50
LD50
NICNAS
NOEC
PVC
SDS
STEL
STOT
SUSMP
SWA
TEELs
TEEL-1
TEEL-2
TEEL-3
TWA
Australian Inventory of Chemical Substances.
Chemical Abstracts Service Registry Number.
The median effect concentration, being a statistically derived concentration of a substance
that can be expected to cause an adverse reaction in 50% of organisms or a 50%
reduction in growth or in the growth rate of organisms.
Globally Harmonized System of Classification and Labelling of Chemicals.
Emergency action code of numbers and letters that provide information to emergency
services especially firefighters.
Soil-Water Partition Coefficient. The ratio of a chemical’s concentration that is adsorbed in
the soil to the concentration of chemical in solution.
Octanol Water Partition Coefficient. The ratio of a compound's concentration in a known
volume of n-octanol to its concentration in a known volume of water after the octanol and
water have reached equilibrium.
The median lethal concentration, being a statistically derived concentration of a substance
that can be expected to cause death in 50% of animals.
The median lethal dose, being a statistically derived single dose of a substance that can
be expected to cause death in 50% of animals.
National Industrial Chemicals Notification and Assessment Scheme.
No-observable-effect-concentration.
Polyvinyl chloride.
Safety Data Sheet.
Short term exposure limit.
Specific Target Organ Toxicity.
Standard for the Uniform Scheduling of Medicines and Poisons.
Safe Work Australia.
Temporary Emergency Exposure Limits. Guidelines designed to predict the response of
members of the general public to different concentrations of a chemical during an
emergency response incident.
The airborne concentration of a substance above which it is predicted that the general
population, including susceptible individuals, could experience notable discomfort,
irritation, or certain asymptomatic, nonsensory effects. However, these effects are not
disabling and are transient and reversible upon cessation of exposure.
The airborne concentration of a substance above which it is predicted that the general
population, including susceptible individuals, could experience irreversible or other serious,
long-lasting, adverse health effects or an impaired ability to escape.
The airborne concentration of a substance above which it is predicted that the general
population, including susceptible individuals, could experience life-threatening adverse
health effects or death.
Time-Weighted Average. The average exposure over a specified period, usually a nominal
eight hours.
Issued by: Jurox Pty Limited
Phone: 1800 023 312
Poisons Information Centre: 13 1126 from anywhere in Australia
ENSAL ENTERIC MIXTURE
Page 7 of 7
References:
ChemID Plus
EPA New Zealand Chemical Classification and Information Database (CCID)
HSDB (Hazardous Substances Data Bank)
This version issued: 29 August 2016 and is valid for 5 years from this date.
Supercedes: This SDS supercedes the version issued on 27 March 2012.
Revision History:
Date of Revision
29 August 2016
Reason
Classification of substance to GHS classification and update of SDS to comply
with SWA Code of Practice.
END OF SDS
Issued by: Jurox Pty Limited
Phone: 1800 023 312
Poisons Information Centre: 13 1126 from anywhere in Australia